Drugs / Rilzabrutinib
Rilzabrutinib
also known as
PRN1008 · SAR444671 · (.ALPHA.E,3S)- · (E)-PRN1008 · (E)-RILZABRUTINIB · PRN1008/SAR444671 · Rilzabrutinib, (.alpha.e,3s)-
Small molecule targets BTK via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Wayrilz | — | 2025-12-22 | europa.eu ↗ |
| Approved | US (FDA) | WAYRILZ | — | 2025-08-29 | fda.gov ↗ |
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06342700 | Mar → Apr 2024 | autoimmune disease | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04748926 | Apr → May 2021 | — | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT06444191 | Jan → Apr 2021 | — | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT06444204 | Nov 2020 → Mar 2021 | liver disorder | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06984627 | Sep 2025 → Aug 2026 overdue | Graves disease | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT06500702 | Dec 2024 → Dec 2026 expected | focal segmental glomerulosclerosis, minimal change disease | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT05104892 | Dec 2021 → Feb 2024 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT05002777 | Dec 2021 → May 2024 overdue | autoimmune hemolytic anemia, warm type | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05107115 | Nov 2021 → Jul 2023 | chronic urticaria | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT05018806 | Sep 2021 → Jun 2023 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT04520451 | Aug 2020 → Oct 2024 | immunoglobulin G4-related sclerosing disease | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT03395210 | Mar 2018 → Jan 2023 | autoimmune thrombocytopenia | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT02704429 | Jan 2016 → Dec 2019 | pemphigus vulgaris | Principia Biopharma, a Sanofi Company | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07007962 | Oct 2025 → Nov 2027 expected | thrombocytopenia due to immune destruction | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT07216079 | Oct 2025 → Nov 2026 expected | autoimmune thrombocytopenia | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07190196 | Sep 2025 → Jun 2028 expected | immunoglobulin G4-related sclerosing disease | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT07086976 | Aug 2025 → May 2028 expected | autoimmune hemolytic anemia, warm type | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06975865 | Aug 2025 → Jul 2027 expected | sickle cell disease | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT04562766 | Dec 2020 → Jan 2025 overdue | autoimmune thrombocytopenia | Principia Biopharma, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03762265 | Jan 2019 → Jul 2021 | pemphigus | Principia Biopharma, a Sanofi Company | Terminated | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-02 | Sanofi | Press Release: Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease sanofi.com ↗ |
| 2026-02-09 | Sanofi | Press Release: Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia sanofi.com ↗ |
| 2025-08-14 | Sanofi | Press Release: Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease sanofi.com ↗ |
| 2025-06-12 | Sanofi | Media Update: EULAR: rilzabrutinib data in IgG4-related disease show reduction in flares and key disease markers; earns Fast Track designation in the US sanofi.com ↗ |
| 2025-06-03 | Sanofi | Press Release: Rilzabrutinib granted orphan drug designation in the US for sickle cell disease sanofi.com ↗ |
| 2025-04-03 | Sanofi | Press Release: Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines sanofi.com ↗ |
| 2024-12-07 | Sanofi | Press Release: ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP sanofi.com ↗ |
| 2024-05-22 | Sanofi | Media Update: New results from rilzabrutinib phase 2 study show potential to be first advanced oral treatment for moderate-to-severe asthma sanofi.com ↗ |
| 2024-04-23 | Sanofi | Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia sanofi.com ↗ |
| 2024-02-24 | Sanofi | Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria sanofi.com ↗ |
| 2022-04-14 | Sanofi | Press Release: Positive Phase 1/2 study results of rilzabrutinib in people with immune thrombocytopenia published in The New England Journal of Medicine sanofi.com ↗ |
| 2021-09-09 | Sanofi | Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus sanofi.com ↗ |
| 2020-11-18 | Sanofi | Press Release: Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia sanofi.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rilzabrutinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06444191 ↗ |
| Known as | (.ALPHA.E,3S)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL3702854 ↗ |
| Known as | (E)-PRN1008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3702854 ↗ |
| Known as | (E)-RILZABRUTINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL3702854 ↗ |
| Known as | PRN1008 | “A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus” NCT03762265 ↗5“An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)” NCT06444204 ↗ “Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)” NCT04562766 ↗ “Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects” NCT06444191 ↗ “rilzabrutinib (SAR444671 [Formerly PRN1008])” NCT04748926 ↗ |
| Known as | PRN1008/SAR444671 | “An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in ParticipantsWith IgG4-Related Disease” NCT04520451 ↗ |
| Known as | Rilzabrutinib, (.alpha.e,3s)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL3702854 ↗ |
| Known as | SAR444671 | “A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active...” NCT07190196 ↗1“rilzabrutinib (SAR444671 [Formerly PRN1008])” NCT04748926 ↗ |
| Action | Inhibit | “BTK inhibitor” NCT02704429 ↗ |
| Modality | Small molecule | — CHEMBL3702854 ↗ |
| Route | Oral | “Oral Treatment With the BTK Inhibitor PRN1008” NCT02704429 ↗ |
| Target | BTK | “BTK inhibitor” NCT02704429 ↗ |